Malignant melanoma is one of the most rapidly increasing cancers in the world. Successful treatment of melanoma depends on early detection by clinicians with subsequent surgical removal of tumors. In recent years, considerable effort has been expended on developing optical methods for characterizing tissue and monitoring changes. In 2014, the Canadian Agency for Drugs and Technologies in Health published a report on optical scanners for melanoma detection, discussing three different devices (Aura, MelaFind, and SIMSYS-MoleMate) approved for marketing in Canada and/or USA. See V. Foerster, “Optical scanners for melanoma detection” [Issues in emerging health technologies, Issue 123]. Ottawa: Canadian Agency for Drugs and Technologies in Health (2014), incorporated herein by reference. As the report confirms, the 5-year survival rate is 93 to 97% for melanoma detected at an early stage, but drops to between 10 and 20% for advanced stage detection, implying that there is a need for accurate diagnostic devices to enable early detection while avoiding unnecessary biopsies. The devices profiled included Aura (Verisante Technology, Inc., Vancouver, British Columbia, Canada), MelaFind (MELA Sciences, Inc., Irvington, N.Y., USA), and SIMSYS-MoleMate Skin Imaging System (MedX Health, Inc., Hamilton, Ontario, Canada).
Aura utilizes near-infrared laser light and Raman spectroscopy to distinguish malignant from benign skin lesions and has shown sensitivities ranging from 90 to 99% for specificities ranging from 58 to 15% for discriminating between benign and malignant lesions.
MelaFind illuminates the skin at 10 wavelengths, measures light scattered back from the skin, and uses image analysis algorithms combined with a skin disorder database to provide treatment suggestion. For discrimination between melanoma and benign pigmented lesions in a population of suspicious lesions, MelaFind showed 98% sensitivity and 9% specificity in a clinical study involving 1,383 patients with 1,831 pigmented skin lesions.
SIMSYS-MoleMate Skin Imaging System is based on using a handheld, multispectral scanner and computer software to provide dermatoscopic images, dermal and epidermal pathological characteristics, and the ability to catalogue, monitor, and compare lesions over time. In a randomized controlled trial involving 1,297 patients with 1,580 suspicious pigmented lesions it was found that adding MoleMate to best practices resulted in lower agreement with expert assessment that the lesion was benign and led to a higher proportion of referrals.
Because so much is at stake with regard to early detection and treatment of cancerous skin lesions, the sensitivity and specificity numbers of the existing optical analysis devices leave room for improvement.